Category Archives: Gene Medicine

EXTON, Pa.--(BUSINESS WIRE)-- Fibrocell Science, Inc. (OTCBB: FCSC.OB - News), a biotechnology company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announces that the June 2011 FDA approval of LAVIV™ (azficel-T) for the improvement of the appearance of “smile line” wrinkles was named the #3 top story of 2011 in cell and gene therapy and regenerative medicine at The 2012 Cell & Gene Therapy Forum in Washington, D.C. The award was voted by The Cell & Gene Therapy Forum survey responders, comprised of Director-level and above leaders in the cell and gene therapy and regenerative medicine industry. The meeting is organized annually by Phacilitate (www.phacilitate.co.uk), a specialist in the organization of exclusive events (www.phacilitate.co.uk/cgt) for leaders from the life sciences community.

“We are delighted and honored that industry leaders attending The 2012 Cell & Gene Therapy Forum have recognized the FDA approval of LAVIV and we hope we continue to impress the industry with our innovations in upcoming years,” said David Pernock, Fibrocell Science Chairman and CEO. “Fibrocell Science is committed to exploring the full therapeutic potential of our personalized fibroblast cellular treatment for use in diverse medical and aesthetic applications.”

About LAVIV™

Approved on June 21, 2011, LAVIV™ (azficel-T) is the first and only personalized cell therapy approved by the FDA for aesthetic use. It is indicated for the improvement of the appearance of moderate to severe nasolabial fold wrinkles (“smile lines”), in adults. The patented technology behind LAVIV is an advanced process that extracts a person’s collagen-producing fibroblast cells from a small skin sample and multiplies them in the Fibrocell Science lab. (The collagen produced by fibroblast cells helps give skin its tone, structure and overall quality. As people get older, the number of fibroblasts decreases and collagen breaks down, resulting in wrinkles and lost skin tone. ) LAVIV is the resulting formulation of a person’s own fibroblast cells, which is then injected into “smile line” wrinkles.

LAVIV is now available in major metropolitan areas throughout the U.S., exclusively through board-certified dermatologists and plastic surgeons who have been trained by Fibrocell Science on the treatment process. A list of trained and certified physicians is available at http://www.mylaviv.com and will be continually updated as new physicians are trained and begin offering LAVIV in their practice.

Important Safety Information About LAVIV™ (azficel-T)

LAVIV is made especially for you from your own skin cells. Using someone else’s cells can cause a serious reaction. Prior to injection, confirm with your physician that your information on the LAVIV vial is correct.

The most common side effects of LAVIV are at the injection-site, including redness, bruising, swelling, pain, bleeding, lumps, irritation, and itchiness. In clinical trials with LAVIV, most injection-site adverse reactions resolved within one week and most required no treatment.

Your health care provider will help you to decide whether you are a candidate for LAVIV and may help you avoid some of the adverse reactions from LAVIV. Before getting LAVIV, tell your healthcare provider if you have any medical problems including allergic reactions to any drugs or food, bleeding disorders or take blood-thinning medicines like aspirin, ibuprofen, or coumadin, keloids or excessive scarring, skin cancer or any malignancy, genetic disorders affecting your skin, immune problems or take medicines that affect your immune system, or any other illness or medical problem. The full Prescribing Information for LAVIV includes additional warnings about adverse reactions that occurred in less than 1% of patients following LAVIV treatment in clinical trials. Talk to your healthcare provider about these warnings.

Please tell your healthcare provider if you are allergic to the antibiotics amphotericin or gentamicin, bovine materials (products made from cattle), or dimethyl sulfoxide (DMSO). Do not use LAVIV if you have a skin infection on your face because LAVIV treatment can make the infection worse.

For more information about LAVIV, please see the Full Prescribing Information at http://www.mylaviv.com.

About Fibrocell Science, Inc.

Fibrocell Science, Inc. (OTCBB: FCSC.OB - News) is a biotechnology company focused on the development of regenerative cell therapy for aesthetic, medical and scientific applications. Fibrocell Science is committed to advancing the scientific, medical and commercial potential of autologous skin and tissue, as well as its innovative cellular processing technology and manufacturing excellence. For additional information, please visit http://www.fibrocellscience.com.

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